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The FDA needs stronger caffeine guidelines

Anna McCartha


I like caffine. Some may say I like it a little too much. However,, I believe the U.S. Food and Drug Administration (FDA) has had major shortcomings in the way of regulating caffeine content.


Caffeine is the most commonly used psychoactive substance in the world with around 85% of U.S. adults consuming caffeine regularly, according to the American Medical Association.


Believe it or not, it is actually in the same drug class as cocaine and methamphetamine.


While the same drug class, they are vastly different. However, caffeine is a stimulant; and prolonged use of high amounts can cause dependency, which can cause withdrawal symptoms when caffeine is not consumed. As of now, the FDA has loose guidelines on labeling and virtually no restrictions on caffeine content.


The FDA requires all food and beverages to clearly state they contain caffeine on their packaging, except products with naturally occurring caffeine such as chocolate and coffee.


While required to state the presence of caffeine, they are not required to state the quantity – that regulation is limited only to over-the-counter caffeine pills. Caffeine pills are also one of only two classifications with a limit on how much caffeine content, alongside soft drinks.


Caffeine pills are limited to 200 mg (21 CFR 340.50) Soft drinks are capped at 0.02%, or 71 mg/12 fl oz (21 CFR 182.1180).


So, one would think that a 12oz Red Bull would have 71mg of caffeine in it. While that is a fair assumption, it is surprisingly incorrect. A red 12 fl oz Red Bull actually contains 114mg.


Energy drinks like Red Bull can get around the restrictions of soft drinks by classifying themselves as “dietary supplements” because of certain herbs that may be used as ingredients. This is not in compliance with guidelines set by the American Beverage Association, which recommends they be classified as beverages. Red Bull’s website even states that it is not promoted as a dietary supplement; however, it does not state that it is not classified as one.


Misuse or overuse of caffeine, as previously mentioned, can lead to dependency and withdrawal. Criteria of dependency can be, but are not limited to, tolerance, withdrawals, a substance used in larger amounts or over a longer period than intended. These metrics are measured throughout 12 months. Three of the criteria must be met over 12 months for Caffeine Use Disorder to be considered under the Diagnostics and Statistical Manual for Mental Disorders 5th.


For these purposes, withdrawals can be defined as negative symptoms that occur after the cessation of caffeine consumption. A 2004 study from The National Institutes of Health found that 10 symptom categories met validity criteria: headache, tiredness/fatigue, decreased energy, decreased alertness, drowsiness/sleepiness, decreased well-being, depressed mood, difficulty concentrating, irritability and foggy-headedness.


In addition, flu-like symptoms, nausea/vomiting and muscle pain/stiffness. Headaches were the most common symptom of withdrawal with 50% of subjects experiencing them after withholding caffeine. Caffeine withdrawals can occur upon abstinence from as low as chronic 100 mg/day consumption. Symptoms typically peak at around 20-51 hours and last 2-5 days. 


Not only can caffeine be dependency-forming, but it can also have effects on the heart.


People who have underlying medical conditions such as Long QT syndrome, which causes an abnormally long repolarization period after the heart beats, may be more sensitive to caffeine. A recent example of this is a student from the University of Pennsylvania who passed away after drinking a 30 oz charged lemonade at Panera Bread, which contained 390 mg of caffeine. This is an example of a failure of proper labeling and advertising of caffeine content. A lawsuit against Panera Bread relating to this instance has recently been settled. 


What can be done to improve labeling and regulation of caffeine content? The most effective way to spread awareness is clear and informative labeling.


When looking at a can of Red Bull or Monster, you can find warnings about who should avoid caffeine and the caffeine content on the label. However, this information is often in a large block of text that can be hard to read.


Alternatively, caffeine content should be placed on the front of the packaging in clear and easy-to-read text, looking something like this “This product contains “xxx” mg of caffeine and is not intended for people under the age of 18, pregnant women or people sensitive to caffeine.”


Simply moving the information to the front of the packaging would allow people to have a better idea of what they are consuming. Along with packaging, caffeine content should be placed on advertising media such as online advertisements and signs at retail stores.  


The most important thing that can be done to improve the regulation of caffeine content is capping the concentration of caffeine in dietary supplements. Beverages classified as dietary supplements (e.g. Red Bull and Monster) should be capped at 10 mg/fl oz or 120 mg/12 fl oz.


This limit would allow companies to still sell some products with the same content; however, some would have to be lowered in content (e.g. Celsius and Reign Storm). 


Caffeine is not evil, and it does have some benefits that I did not mention. I do not believe that caffeine should be outlawed or a controlled substance. What I believe is that the FDA has mismanaged the regulation of caffeine content and labeling as a way to promote public health.

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